Orelox children and infants 40mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFPODOXIME

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

J01DD13

INN (International Name):

CEFPODOXIME 40 mg/5ml

Pharmaceutical form:

GRANULES FOR ORAL SUSPENSION

Composition:

CEFPODOXIME 40 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2005-09-28

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ORELOX
®
40 MG/5 ML GRANULES FOR ORAL SUSPENSION
CEFPODOXIME PROXETIL
IN THIS LEAFLET:
1.
What Orelox 40 mg/5 ml granules for oral suspension are and what they
are used for
2.
What you need to know before you use Orelox children and infants 40
mg/5 ml
granules for oral suspension
3.
How to use Orelox 40mg/5 ml granules for oral suspension
4.
Possible side effects
5.
How to store Orelox 40 mg/5 ml granules for oral suspension
6.
Contents of the pack and other information
1.
WHAT ORELOX 40 MG/5 ML GRANULES ARE AND WHAT THEY ARE USED FOR
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code:
J01DD13.
(J: Anti-infectives).
This medicine is an antibacterial antibiotic belonging to the
beta-lactam group.
This medicine is used in children to treat certain bacterial
infections susceptible to this drug.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ORELOX 40MG /5 ML GRANULES
DO NOT USE ORELOX 40 MG/5 ML GRANULES FOR ORAL SUSPENSION:
•
In children with a known allergy to cephalosporin antibiotics.
•
In children with phenylketonuria (hereditary disease screened for at
birth), because this medicine contains
aspartame.
WARNINGS AND PRECAUTIONS FOR USE
•
Any signs of allergy (skin rash, itching, etc.) during treatment must
be reported to your doctor immediately.
•
There is a 5-10% possibility of an allergic reaction in patients who
are allergic to penicillin.
•
Inform your doctor of any allergy or allergic reaction that occurred
during treatment with antibiotics
belonging to the penicillin group.
•
Diarrhea occurring during treatment with antibiotics must not be
treated without seeking medical advice.
•
As this medicine contains lactose, sorbitol and sucrose, it must not
be given to patients with fructose
intolerance, galactosemia, glucose and galactose malabsorption
syndrome, or lactase or sucrose
isomaltase deficiency (rare metabolic diseases).
•
It is important that you inform your doctor if the child has kidney
disease, as the treatment will need to be
adjusted.
•
Use

Summary of Product characteristics

Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orelox children and infants 40 mg/5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefpodoxime proxetil
................................................................................................................
6.261 g
Equivalent amount of cefpodoxime
............................................................................................
4.800 g
For 100 g of granules.
16.7 g of granules is equivalent to 100 ml of reconstituted
suspension, i.e. 200 graduated doses.
Excipient with known effect: lactose, sucrose, sodium, aspartame
(source of phenylaline) (E951),
potassium,sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The therapeutic indications of cefpodoxime are based on its
antibacterial activity andpharmacokinetic
properties.
In children, they are limited to the treatment of infections due to
bacteria susceptible to cefpodoxime, in
particular:
•
Acute otitis media.
•
Documented group A beta-hemolytic streptococcal sore throat.
•
Sinusitis.
•
Lower respiratory tract infections.
Consideration should be given to the official guidance on the
appropriate use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The oral suspension is recommended for use in children. In certain
cases, use of a tablet can be considered
in approved pediatric indications at approved pediatric dosages, if
the child is able to swallow the tablet.
DOSAGE
_Children with normal kidney function: _
The mean dosage is 8 mg/kg/day, without exceeding the adult dose (200
mg/day for sore throat and 400
_mg/day for all other indications), administered in 2 divided doses at
12-hour intervals. _
Page 2
_ _
Duration of treatment for sore throat is 5 days.
_Kidney failure: _
If creatinine clearance is over 40 ml/min/1.73m², the dosage for
patients with normal kidney
function should be referred to.
If creatinine clearance is below 40